Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00006231|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma Perioperative/Postoperative Complications||Procedure: quality-of-life assessment Procedure: standard follow-up care Radiation: radiation therapy||Phase 3|
- Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma.
- Determine whether the nodules that develop after radiotherapy are symptomatic in these patients.
- Compare the quality of life of patients treated with radiotherapy vs standard care alone.
OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed.
- Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months.
Patients are followed at 1, 2, 4, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Official Title:||A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma|
|Study Start Date :||February 1998|
|Actual Study Completion Date :||December 2002|
- Incidence of metastatic skin nodules
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006231
|West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Gartnavel General Hospitall|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Stobhill General Hospital|
|Glasgow, Scotland, United Kingdom, G21 3UW|
|Study Chair:||Noelle O'Rourke, MD||University of Glasgow|